AC-2024-LON-001142 - [2025] EWHC 2015 (Admin)

Outcome irrationality

Regardless of the rationality of the process adopted by the CQC, the claimants further contend that its conclusion that IP1’s registration should be continued, absent further condition, was not one that was rationally open to it. Having regard to the five matters identified, it is the claimants’ case that, applying the appropriate level of heightened scrutiny, the range of rational decisions was so narrow as to determine the outcome (per Pham at [107]): either the CQC had to impose a condition which rationally ensured patient safety, or, if that were not possible, it was bound to decide not to continue the registration; it could not reasonably treat the continuation of the registration as sufficient to ensure patient safety. In support of this case, the claimants point to the patient data, showing that, for the period 1 July 2023 to 30 June 2024, all 69 referrals of 16-17 year olds from Kelly Psychology had been accepted by IP1 (albeit three patients had had to undergo a period of further assessment or treatment); in contrast, since at least April 2024, no new referrals have been made for hormone treatment for anyone within this age range within the NHS in England (or Scotland).

Before returning to the specific points relied on, I should first address the question of the patient data figures referenced in the claimants’ argument. As Ms Huntley has observed in her evidence, the difficulty with these figures is that they are not comparing like with like. The NHS data refers to referrals of new patients post April 2024, which provides no information regarding the position of those already on the waiting list. Even focusing on the absence of referrals of such new patients, however, it has to be born in mind that those being considered by the national NHS MDT will include children below the 16-17 age group relevant to the hormone treatment provided by IP1, and there are likely to be other differences between the two groups of patients which might explain different referral rates. In any event, given both NHS waiting lists and the time required for assessment before cases are referred for consideration by the national MDT, it may well be that few cases have reached that stage in the process. As for IP1, as the claimants have themselves pointed out, Kelly Psychology and IP1 operate an integrated service; if the assessments undertaken by Kelly Psychology are carried out with due rigour, applying the appropriate degree of caution in making referral decisions for the hormone treatment, it might not be particularly surprising if there was then a high acceptance rate of those referrals by IP1.

Allowing that there could come a time when a long-term and striking disparity in referral numbers might make this a relevant consideration for the CQC, that is not provided by the current evidence. Even if such data was to be considered relevant, however, it is hard to see how this could be determinative. As Ms Huntley has pointed out, it is not the CQC’s role to review each and every treatment decision: whether or not an appropriate clinical decision has been made to treat an individual patient with the hormone treatment must be a matter for specialist knowledge, exercising a clinical expertise and judgment outside the remit of the CQC and falling, instead, within the purview of the individual clinician’s professional body.

Referrals to IP1 by non-CQC regulated entity. Although a relevant consideration (and seen as such by the CQC), the evidence shows that this is not an unusual feature for the CQC: regulated providers (including those who offer TDDI services for vulnerable children) will often work with unregulated entities and may accept patient self-referrals. Neither the HSCA nor the 2014 Regulations prohibit such arrangements and, allowing for the particular context of the decision under challenge in these proceedings, I cannot see that this feature meant that the CQC was bound to refuse IP1’s registration. Indeed, at the registration stage, section 12(2) HSCA requires the CQC to make a binary determination: if satisfied that the provider is complying with the requirements of the relevant regulations, and will continue to do so, it must grant an application for registration; if not, it must refuse it. That requires an assessment of compliance/the likelihood of continued compliance; the answer will not be provided simply by reference to the fact that a CQC-regulated provider might accept referrals from an entity falling outside the CQC’s remit. As for the subsequent assessment decision, while that involved a rating exercise, the CQC evaluated IP1 against standards that were clearly tied to the requirements of the 2014 Regulations; having assessed IP1 as “outstanding” in the majority of categories, it cannot be said to be irrational for it to have continued the registration without imposing further conditions.

At each stage, the substantive question for the CQC was whether the provision of the regulated activity complied with the relevant regulations. In answering that question, it was entitled to take into account the safeguards provided by the professional regulatory standards to which the individuals within both IP1 and Kelly Psychology were bound. Beyond that, however, the CQC had regard to how patients arrived at the service provided by IP1, with the integrated nature of the relationship between IP1 and Kelly Psychology affording the CQC visibility over the quality of the latter’s referrals and its treatment of patients. As for the CQC’s assessment of IP1, having found demonstrable compliance with the fundamental standards, it was entitled to see that as mitigating any risks arising from the fact that IP1 was accepting referrals from an entity that fell outside the CQC’s remit. The detailed findings made by the CQC in these respects have not been challenged; these attest to the high standards of care provided to patients throughout the integrated service operated by Kelly Psychology and IP1. On the evidence, I cannot see that the relevant decisions reveal any irrationality as to outcome in this regard.

Referrals to IP1 from an entity that provides only non-medical psychological treatment. The comparison being made in this regard concerns referrals to the NHS gender service, not to subsequent providers of the hormone treatment. Given that it was concerned solely with the regulation of IP1, it is unclear as to how it is suggested that the CQC ought to have approached this factor when reaching its conclusions on registration or in its subsequent assessment. In any event, it is apparent that the assessment process led by Ms Huntley had regard to the explanation for this requirement (as identified in the NHS consultation report of 7 August 2024) and was satisfied that the service provided, viewed as a whole (including the assessment stage at Kelly Psychology), demonstrated a holistic approach to treatment planning, with referrals back to the patient’s GP, and with specific training for staff to support patients with additional needs. Taking into account this difference between IP1 and the NHS service, but having regard to the detailed findings made on the CQC’s assessment (which have not been the subject of specific challenge in these proceedings), I am unable to conclude that the conclusion reached was outside the range of rational responses open to the CQC. Moreover, having found that, measured against the requirements of the 2014 Regulations, IP1 was to be rated “outstanding” overall, I cannot see that the CQC can be said to have reached an irrational conclusion in not imposing any further condition on IP1.

IP1 is inextricably intertwined with Kelly Psychology; both entities operate “for profit”, and there is a risk that decision-making will be influenced by considerations of mutual benefit. As I have already observed, the potential for conflicts of interest will be a relatively common feature in the independent sector that the CQC regulates. When considering this under the heading of outcome irrationality, a direct comparison with the NHS is inapt: there is no intrinsic reason why the private sector should be forced to mirror the public sector in terms of working structures and relationships (even if that was a reasonably practicable option); the issue for the CQC must be whether it is satisfied as to the provider’s compliance with the requirements of the relevant regulations.

The claimants’ case in relation to this point affords no weight to the professional obligations owed by individual practitioners at IP1 and Kelly Psychology, although such professional regulation will provide a significant and important safeguard in the provision of regulated TDDI services. The CQC’s registration and assessment decisions did not, however, rest solely on that point; those decisions were based on the detailed evaluations carried out in each instance and, although alive to the structure of IP1’s business, and its links with Kelly Psychology, the CQC found no evidence of improper decision-making or anything else that could give rise to a legitimate concern relevant to patient safety or well-being. The claimants’ case does not engage with the findings made by the CQC at either the registration or the subsequent assessment stages, but those findings demonstrate why there was no irrationality in the decisions reached, and why it was not irrational for the CQC to consider IP1’s registration should not be subject to further conditions.

There are clear differences between IP1’s MDT and the NHS national MDT. In this regard, the claimants contend that the CQC’s finding that IP1’s MDT was “sufficiently aligned” with the NHS national MDT was outside the range of reasonable conclusions open to it, objecting that the only basis for that conclusion was the presence of Dr Adams, who was not truly independent and who could not provide the same breadth of specialist input available within the NHS.

I do not accept that the claimants’ case provides a fair characterisation of the CQC’s reasoning in this regard. Although the presence of Dr Adams in all referral decisions relating to 16 and 17 year olds was certainly an important factor, it is also apparent that Ms Huntley and her colleagues had regard to other features of IP1’s referral decisions that were also relevant to the conclusion reached. Thus, regard was had to the prior process of assessment, over some six months, by Kelly Psychology; it was also considered relevant that IP1’s MDT – which was (as the name suggests) itself multi-disciplinary – would involve psychologists from Kelly Psychology who were not themselves involved in the care of the patient under discussion; in relation to Dr Adams, accepting that she would be paid a fee by IP1, it was nevertheless apparent that she would have no continuing interest in whether or not a referral was agreed; at the same time, conscious of the majority presence of representatives of IP1 and Kelly Psychology, the fact that consensus agreement was required was seen to ensure that Dr Adams’ independent viewpoint could not be outvoted; and, significantly, Ms Huntley had herself sat in on IP1’s MDT discussions and formed her own view as to the safeguards it provided.

Returning then to the comparison with the NHS national MDT, accepting that IP1 could neither access the NHS structure, nor precisely replicate it, I have gone back to consider the stated purpose for requiring referral decisions to be taken by the national MDT; that is, to ensure the patient understands the limited clinical evidence as to the effects and harms of the hormone treatment at ages 16-17, and that such treatment involves a significant decision with long-term indications. Accepting the way in which it has been decided that this purpose is to be achieved within the NHS, I do not consider that this requires that referrals for hormone treatment for 16 and 17 year olds can only be determined by the NHS national MDT, or a precise replica. That would effectively mean there could be no private provision of the hormone treatment for this age group, which is not a limitation that has (yet) been imposed (accepting that this is an area where there may well be further regulation). Allowing, therefore, that there was a range of responses open to the CQC in assessing IP1’s decision-making structures, the real question is whether its conclusion was compatible with the cautionary approach that underpins the NHS model to which IP1’s process was being compared.

Again, the detailed evidence provided explains the decision reached; in particular, Ms Huntley’s statement sets out what she witnessed when sitting in on IP1’s MDT discussions and why this supported the conclusion arrived at on the assessment. It is apparent that Ms Huntley had in mind the purpose of the NHS MDT, and was focused on whether the structure put in place by IP1, even if not the same, was sufficiently aligned as to be able to meet that purpose. Relevantly, further detailed consideration was given to other aspects of the consent process, with the assessment report again setting out the various features that weighed with Ms Huntley (and her colleagues) in this regard. Accepting that IP1 could neither access the NHS national MDT nor precisely replicate it, but keeping in mind the purpose of the NHS model, I cannot say that the CQC’s finding of sufficient alignment was outside the reasonable range of conclusions open to it.

IP1 and Kelly Psychology advocate for the hormone treatment. For the reasons I have already identified, this is a point that I consider can only sensibly relate to the statements made by/attributed to Dr Kelly. It is, however, not part of the claimants’ case that Dr Kelly could not be a nominated individual, and it must be allowed that he is entitled to hold and express views about the provision of gender services. The substantive question for the CQC was as to whether those involved in the provision of regulated activities through IP1 were able to demonstrate compliance with the regulatory requirements; it determined this question through its investigation of the professionalism demonstrated by those involved in the management of IP1, which included Dr Kelly and which extended back to consideration of whether there were any recorded concerns relating to his previous work at Tavistock GIDS.

The CQC’s findings at both registration and assessment stages are set out in the relevant reports. No issue has been taken with those findings, which explain why the CQC found the professionalism of IP1, and its senior leadership team, to be commensurate with a well-run service. Even viewing the statements relied on by the claimants alongside the patient referral data, I cannot see that would suggest that the conclusions reached by the CQC were other than within a reasonable range. As I have already observed, to the extent that regard was to be had to comments by/attributed to Dr Kelly in various newspapers, it would be necessary to consider these in the light of other statements he had made, including in academic journals or conference papers. As for the patient data, I have already referenced the problems that arise in seeking to compare these figures with NHS referrals. Even if just considering patient referrals to IP1, regard would also need to be given to the fact that a significant number of those assessed by Kelly Psychology are not referred for the hormone treatment. Yet further limiting consideration to patients referred to IP1, a high rate of acceptance would be entirely compatible with the assessment process having been undertaken with due rigour, exercising the degree of caution recommended by the Cass Review. Certainly, the evidence available in this regard does not provide a basis for concluding that the CQC did other than reach decisions that were within the reasonable range.

Outcome irrationality: an overview. Having considered each of the five factors individually, I have again sought to stand back to consider the outcome irrationality challenge take as a whole. Thus, undertaking the anxious scrutiny required, I have taken into account the conclusions reached by the Cass Review and the recommendations in the final report, understanding that these have informed changes to NHS policies that have, in turn, been accepted as providing relevant comparisons for the CQC’s assessments of IP1. For the claimants it is contended that this is a case where there ought properly to have been only one answer (per Pham), such that IP1’s registration, or continued registration, ought to have been refused or subjected to the imposition of a condition akin to the requirement for a second opinion from independent and impartial persons required in equivalent circumstances within the NHS. In advancing that argument, the claimants have at times come close to suggesting that the provider of the regulated TDDI activities in this context would have to operate as part of the NHS. Acknowledging that this might be a matter for the on-going policy debate in this area (and I am mindful of the fact that an expert working group is due to report on the use of the hormone treatment for children), I am unable to see that this is a requirement that can be read into the legislative and regulatory regime currently in place.

Thus accepting (as I do) that the range of rational decisions open to the CQC allowed for the possibility of it approving the registration/continued registration of IP1 as a private provider of the hormone treatment, I would, however, agree that the extent of the range is necessarily informed by the findings of the Cass Review and the NHS response to those findings. In this respect there is a degree of common ground: the CQC accepts that the standards set by the NHS will be relevant to the assessments it makes in regulating the healthcare sector, and IP1 has made clear that it has looked to NHS policies in establishing its own structures and procedures. Where, however, IP1 was unable to precisely replicate the NHS process, I consider it was open to the CQC to look to the objectives that the NHS was seeking to achieve and to use those as the relevant standard against which to assess IP1; thus the range was set by reference to the substance that underpinned the NHS structures, not merely the choices made as to the form that those structures should take. Applying that approach (as I am satisfied the CQC did) the decisions reached fall within the rational range, and the CQC was entitled to conclude that no further conditions were required.